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On August 1, 2014, the family of a Virginia man filed a testosterone wrongful death lawsuit in the U.S. District Court for the District of Utah. The plaintiffs have named Androderm manufacturers Actavis and Watson Pharmaceuticals as defendants in the case.

This is one of many personal injury lawsuits filed by patients who have allegedly suffered serious side effects as a result of taking testosterone replacement therapy. In June 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal cases into the Northern District of Illinois.

Androderm Allegedly Leads to Stroke

According to the complaint, the Virginia man was 64 years old when he experienced symptoms he attributed to low testosterone levels. He was prescribed and took Androderm from about October 2005 to February 2008. He then used it again between July 2008 and May 2012. Prior to taking the drug, he had no history of blood clots or stroke.

In October 2011, however, he was diagnosed with deep vein thrombosis (DVT). This is a disorder in which a blood clot can become lodged in the deep veins of the body, usually in the lower legs or thighs. It is a dangerous condition, as the clot may break off and travel through the bloodstream to other organs in the body, where it may cause significant damage.

The plaintiff didn’t believe at the time that Androderm had anything to do with his DVT.

On June 21, 2012, the plaintiff suffered a stroke. He suffered a second one on July 24, 2012, which led to his death on August 3, 2012. His family alleges in their complaint that had the defendants properly disclosed the risks associated with testosterone replacement therapy, the plaintiff would have avoided the risk of DVT and stroke either by avoiding the drug completely, or by reducing the dose and length of use.

Defendants Overpromoted Androderm

The FDA approved Androderm in 1995 for use in men diagnosed with hypogonadism, which is a condition in which a man’s body doesn’t produce enough of the male hormone, testosterone. Symptoms may include infertility, erectile dysfunction, decrease in muscle mass, and loss of bone mass.

The plaintiff claims that after the FDA approval, however, the defendants “engaged in media campaigns to convince men who were experiencing the typical effects of the aging process that they were suffering from low testosterone, which could be treated with testosterone supplements, including Androderm.” The defendants also allegedly launched a campaign to convince doctors that low testosterone levels were more common than previously believed.

Recent studies have raised concerns over widely prescribing testosterone replacement therapies. In January 2014, research published in PLoS One found that men over the age of 65 who took testosterone injections or used testosterone gel had double the risk of heart attack after starting the treatment than men who didn’t take it. An earlier 2010 study was halted early because men who were taking testosterone therapy products were more likely to suffer cardiovascular-related health problems.

In January 2014, the FDA announced they were looking into the potential risks of stroke, heart attack and death in men taking testosterone products.

The plaintiffs bring counts of failure to warn, negligence, breach of warranties, fraud, negligent misrepresentation, wrongful death, and survival action. They seek general, compensatory, and punitive damages.

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